Quality Assurance for the Biotech Industry

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

In the eyes of regulatory authorities and the biotech industry, the quality assurance and quality control issues of biologics are different from chemical drugs because of: (1) use of living source materials to produce the biologic, (2) increased complexity of biologic manufacturing processes and (3) increased complexity of the biologic molecules themselves. While chemical drugs can become generics, biologic products are best viewed as biosimilars, and not as bio-generics.

Why This Course Matters

Biologics are highly susceptible to adventitious agent contamination – prions, viruses, mycoplasmas, and bacteria/fungi microbes. Risk control procedures – such as barriers to entry, testing to confirm absence, and inactivation/removal – are essential. Lessons can be learned from reported contaminations of biologic manufacturing processes. Compared to chemical drugs, biologics have a more complex process-related impurity safety profile, especially due to the living system-related impurities (e.g., host cell proteins, host cell DNA).

Extensive physicochemical characterization of protein and monoclonal antibody molecular structure, employing multiple, complementary, as well as orthogonal, state-of-the-art analytical methods is necessary, covering primary amino acid sequence changes (e.g., truncation, deamination, oxidation), post-translational modifications (e.g., glycosylation), and higher order structural changes (e.g., secondary folding, aggregation). Because of the molecular structural complexity of a biologic, including its many possible structural variants, functional activity assays are required that can discern which structures have what amount of potency. While bioassay functional activity assays (i.e., in vivo, in vitro) are required for measuring potency, surrogate (analytical) assays can be used if properly correlated to the bioassays. At times, an assay matrix may even be required. Many manufacturers underestimate the amount of resources and time needed to properly implement these functional activity assays.

Who Should Attend?

This three-day quality assurance (QA) and quality control (QC) training course is designed for management and professional staff involved in, or interested in quality assurance and quality control support for biologics and biopharmaceuticals. This course will be of particular interest to QA and QC personnel and management, Regulatory Affairs, Manufacturing, Process Development and Analytical Development staff, and anyone involved with the biotech industry.

This quality assurance and quality control course will help the attendee to develop an effective risk management strategy for biologics, addressing the quality challenges all the way from Phase 1 clinical studies through commercialization. Guidance from the FDA, EMA and ICH will be discussed. In addition, the differences in managing quality for chemical drugs vs biologics will be examined.

John Geigert, Ph.D.

John Geigert, Ph.D.

Specialties: Regulatory, Biotechnology, Management

John Geigert, Ph.D., RAC, is President of BioPharmaceutical Quality Solutions, which for the last 12 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.

Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development for Cetus Corporation in Emeryville, CA. At these companies, he led the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products (4 recombinant proteins and 2 monoclonal antibodies) now commercially available in the U.S. and Europe.

He has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board, and served as an expert member of the USP Biotechnology Committee.

He obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.

Courses:

• CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics

Publications:

Dr. Geigert is the author of the book The Challenge of CMC Regulatory Compliance For Biopharmaceuticals (and Other Biologics), with the 2nd edition released in 2013. He has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus: "What Senior Management Needs to Know About CMC Regulatory Compliance For Biotech Products" (Aug-Nov 2009, 4-part series); "Demystifying CMC Regulatory Strategy" (Sept 2011-Mar 2012, 4-part series).